The Adrenal Contribution to Androgen Production in Girls During Puberty

University of California San Diego

Status and phase: Completed; Phase 3

Conditions: Development

Treatments: Drug: Dexamethasone; Drug: Adrenocorticotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT01062568

091676

Details and patient eligibility

About

In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare steroid changes before and 60 min after ACTH administration in NW and OB girls.

Full description

Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin hormone (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.

Enrollment: 50 patients

Sex: Female

Ages: 7 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal CBC (Hemoglobin must be at least 11mg/dl)
• Normal renal and liver function tests (AST& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk phos 30-130 IU/L;
• direct bili <0.2 mg/dL;
• total bili <1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)

Exclusion criteria

• Pregnancy
• On oral contraceptives
• On insulin lowering drugs
• On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
• On medications that will influence androgen metabolism or clearance
• On medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconazole, etc)
• Subjects with morning cortisol<5 ug/dL will be excluded and asked to see their primary care physician.
• Subjects with 17-OHP>250 ng/dL) will be excluded and asked to see their primary care physician.
• Subject with a history of Cushing syndrome or adrenal insufficiency will be excluded

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Obese group

Experimental group

Description:

Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.

Treatment:

Drug: Adrenocorticotropin

Drug: Dexamethasone

Nonobese group

Experimental group

Description:

Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.

Treatment:

Drug: Adrenocorticotropin

Drug: Dexamethasone